The FDA has posted new draft regulations on its website. While these guidelines aren’t binding, they will help improve approval process by avoiding problems with omitting or minimizing important risk factors and information.

The FDA will take public comment for 90 days before issuing new guidelines.

Now the guidelines suggest instead of generally stating "certain monitoring" the label should state exactly what type of monitoring is needed along with its frequency. For example, certain monitoring should be replaced with monthly blood tests for liver damage.

The FDA will be reviewing the "net impression" of advertising to determine if the information relays an accurate impression.

For example, smiling people, changing camera angles, and upbeat music may obscure the more serious message of the potential for harm. The FDA could consider these tactics as overall misleading impression.

Last year, a congressional hearing criticized Schering-Plough’s Nasonex, an anti-allergy medication ad campaign. The ad featured a bee that flew around during a description of side effects but simply hovered while benefits were explained.

For more information please see:

http://www.fda.gov/cder/guidance/7427dft.pdf

http://online.wsj.com/article/SB124339082067457033.html

http://www.reuters.com/article/latestCrisis/idUSN26516199

Labels: FDA, guidelines, monitor, Nasonex, regulation

Under Peruvian law, there is a procedure called "restructuring of assets", by which creditors of a company can ask the Peruvian agency, INDECOPI (a self-governing body parallel to the judiciary but under the administrative arena) can request restructuring of the company and seek to be appointed to a board of creditors that will administer the company that is declared to be restructuring.

Generally, the largest creditors are companies related to the company ‘in restructuring” and are those who comprise the board of creditors, ie, they continue to administer the company.

Yesterday the Peruvian Government issued an emergency ordinance which changes the rules of the board, and establishes that related companies that cannot be part of the board of creditors and shall not vote on the management restructuring.

This new rule is rumored to be directed at the Doe Run Company, a St. Louis, Missouri-based company which owns a lead smelter and refinery in La Oroya, Peru. Under Doe Run's ownership of this metallurgical complex, La Oroya has become officially one of the 10 most polluted places on earth. Nearly 100% of the children of La Oroya have blood lead levels that exceed the level considered hazardous by world standards, including those of the CDC and the World Health Organization. The Doe Run Company, in turn, is owned by New York-based Renco Group, whose owner is Ira Rennert. Rennert and the Renco group have been responsible for the pollution of various sites in the United States.

The emergency degree issued yesterday by the Peruvian government suggests that the US-based Doe Run Company may lose control of the Peruvian complex. The following is an article (translated into English) that appeared in the Peruvian newspaper, El Comercio, yesterday.

NEW RULES OF THE GAME FOR LA OROYA

Doe Run Smelter may not manage the company

The protagonists in the difficult situation of Doe Run, the Government, the company in question, and the mineral suppliers, are still playing, slowly, their chips. The last move made yesterday, by the Government, was to issue an emergency decree modifying the conditions for companies that might enter into a restructuring process, which could be precisely the case for Doe Run.

The mining company, owner of the smelter and refinery in La Oroya, maintains a debt of more than $100 million with its providers of concentrates and $20 million with others companies that provide it services. However, the principle debt is to its American parent, Doe Run Resources (Renco Group), to which it owes $156 million.

Creditors of the mining company were fearful that the Renco Group would request the insolvency of Doe Run Peru before Indecopi. According to the amount of debt, this allows new control of the company through a board of creditors that are appointed to administer the company.

Emergency Decree 61-2009, issued yesterday, decreed that creditors considered related to the debtor may not request the insolvency of the company or vote at a creditors’ meeting, the body that administers the company in restructuring.

The minister of Energy and Mines, Pedro Sanchez, said that this rule has not been given specifically for the Doe Run case. He argued that this is a generic standard, because in a crisis situation many companies seek restructuring before Indecopi.

However, several government sources indicated that this was a provision designed to prevent Doe Run from “declaring insolvency, taking the money itself, and leaving.”

Executives of the mining company analyzed the scope of the decree yesterday afternoon. The manager of community relations and current spokesman for Doe Run, Jesus Perez, said that they were evaluating the issue, without giving further details.

SPANISH STANDARD

Hugo Silva Quintanta, bankruptcy specialist and partner of Rodriguez, Diaz, and Medrano, explained that the Government’s emergency decree is no an isolated rule, as this applied in Spain.

“It is because in many cases, the related creditors hinder the process, impede restructuring, or generate fictitious restructurings,” said Silva Quintana.

Fernando Martinon, partner of Muniz, was against the rule because it cuts illegitimately into the rights of the related companies. He said that, regardless of the Doe Run issue, there exist companies and shareholders that present capital to related companies, which lose their political rights, since they could not vote at a meeting of creditors.

GOING TO INDECOPI?

For Doe Run to enter into any restructuring, each company to which the company owes 50 UIT (S/ .177.500) can ask for a declaration of insolvency before Indecopi.

Ricardo Trovarelli, general manager of Cormin, one of the creditor companies of Doe Run, said that they were not interested in declaring Run Peru insolvent because it would virtually freeze their debt.

He also said that creditors would have to put money back into the smelter and refinery to get it on tract. “The debt would be charged when the company profits, it would take a long time,” he said.

Jose Miguel Morales, legal representative of the Buenaventura Mining Company, which is also a creditor of Doe Run Peru, said that the mineral providers would meet with Doe Run Peru next Monday, but will define the agenda today.

Minister Pedro Sanchez said that so far, they have not received any proposal to modify the Environmental Management and Adaptation Program (PAMA) of Doe Run, whose completion is due in October. The minister that he expects to receive today Doe Run’s proposal to become operational again.

MORE INFORMATION

The two problems of the mining company:

The mining company faces two problems.

• The first is the financial aspect: it has debts, and the banks are unwilling to provide working capital.
• The second problem is the performance of its PAMA, which requires investing $70 million. According to the mining company, it can not fund it still.

To see the Spanish version of the article, click here: http://www.elcomercio.com.pe/impresa/notas/doe-run-podria-dejar-administrar-fundicion/20090529/293114

Labels: Doe Run, emergency decree, La Oroya, Peru, Renco, Rennert

The Food and Drug Administration (FDA) decided to issue a public health advisory about the danger of liver damage from Hydroxycut use after compiling a total of 23 reports of liver injury associated with Hydroxycut use, including one death from liver failure. According to a letter to the editor published in the April 14, 2009 issue of the World Journal of Gastroenterology, current reports of liver damage from Hydroxycut may underestimate the actual numbers by "several orders of magnitude."

Did you take Hydroxycut? Are you concerned that you may have suffered liver damage as a result? Here are symptoms to look out for:

• Yellowing of the skin and/or whites of the eyes (jaundice)
• Brown or dark-colored urine
• Pale stool
• Nausea, vomiting, or loss of appetite
• Pain or sensitivity in the stomach or abdomen
• Excessive fatigue or shortness of breath
• Weakness or muscle pain
• Itching
• General feeling of being unwell

If you are currently taking Hydroxycut and are experiencing these symptoms, you may have suffered liver damage. If you experienced these symptoms in the past, but stopped using Hydroxycut and the symptoms cleared, you may have suffered liver damage. If you were diagnosed with hepatitis while or after using Hydroxycut, your liver damage may also have been associated with Hydroxycut.

If you believe you or a loved one may have suffered liver damage as a result of taking Hydroxycut, please schedule a Hydroxycut injury consultation with the product liability lawyers at Schlichter, Bogard & Denton today.

Labels: drugs, FDA, Hydroxycut, liver damage

A Singapore man undergoing treatment was detained by U.S. immigration officials after the drug he was taking caused his fingerprints to disappear. The man, identified as Mr. S, was eventually allowed to enter the United States after officials determined he did not pose a threat to security.

According to Mr. S’s oncologist, Eng-Huat Tan of the National Cancer Center in Singapore, the patient had neck and head cancer that spread. Although Mr. S responded well to chemotherapy, to prevent a recurrence doctors placed him on Capecitabine, a drug marketed in the United States as Xeloda. One of the side effects of the drug is hand-foot syndrome. It causes the skin o n the hands and feet to peel. Eventually over time, the drug erases fingerprints.

“It is uncertain when the onset of fingerprint loss will take place in susceptible patients who are taking Capecitabine”, Dr. Eng-Huat Tan wrote. “However, it is possible that there may be a growing number of such patients as Mr. S. These patients should prepare adequately before traveling to avert the inconvenience that Mr. S was put through.”

For more information see: http://news.bbc.co.uk/2/hi/health/8064332.stm

Labels: cancer, chemotherapy, doctors, fingers, Singapore

The Food and Drug Administration (FDA) has reported that doctors are not consistently recognizing histoplasmosis and other invasive fungal infections in patients taking Tumor Necrosis Factor-alpha (TNF-α) blockers: Cimzia, Enbrel, Humira, Remicade and Simponi. TNF-α blockers are commonly used to treat moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis or chronic arthritis in the spine.

The failure to recognize fungal infections has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death.

Centocor Ortho Biotech and FDA recently reminded healthcare professionals of these risks associated with the TNF-α blocker Simponi. Centorcor Ortho Biotech of Horsham, PA manufactures Simponi.

Patients who develop an infection, including any persistent or reoccurring infections should have their Simponi or other TNF-α blocker discontinued. Empiric antifungal therapy should be considered until the source of the infection is identified. It may be appropriate to consult an infectious diseases specialist.

Patients and health care professionals are encouraged to report and to monitor signs of infection and be closely monitored during and after treatment with TNF-α blockers for invasive fungal infections. Symptoms include fever, malaise, weight loss, sweats, cough and dyspnea, pulmonary infiltrates on X-ray or serious systemic illness.

Patients who reside in or travel to regions where fungal infections are endemic like the Ohio and Mississippi River valleys and southwestern United States should be tested for invasive fungal infections if they develop a serious systemic illness.

All adverse events should be reported to Centocor Ortho Biotech or the FDA. It is important that all adverse events potentially associated with Simponi be reported so that the drug’s profile is updated appropriately as post-approval experience is gathered.

Centocor Ortho Biotech Inc. can be contact at 1-800-457-6399.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/medwatch/safety/2009/SIMPONI_DHCP%20letter_May09.pdf
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Simponi

Labels: ankylosing spondylitits, arthritis, Cimzia, enbrel, FDA, fungal infections, humira, posriatic arthritis, remicade, rheumatoid arthritis, Simponi, spine, tnf-a

Those suffering from Type II diabetes, beware. The FDA has recently announced that they are issuing a new Black Box warning on the Type II diabetes medicines, Actos and Avandia. Both of these drugs have been connected with an increased risk for heart attacks and heart-related deaths. Anyone who has taken Actos or Avandia could potentially be at risk.

The warning urges physicians prescribing Actos and Avandia to watch their patients for signs of heart problems. Some symptoms of a heart problem are: shortness of breath, edema (retaining of fluid causing swelling of extremities), and excessive or rapid weight gain. Anyone experiencing any of these symptoms and taking Actos or Avandia should contact their doctor immediately.

Type II diabetes is a disorder that is characterized by high blood glucose due to an insulin deficiency. The insulin resistance is caused because the cells do not respond appropriately to insulin. Unlike Type I diabetes, Type II is a problem of cellular response to insulin rather then a problem with the production of insulin. The prevalence rate of diabetes have doubled from 1990-2005, causing the Center for Disease Control to declare it an epidemic.

For more information see:
The FDA warning: http://www.fda.gov/medwatch/SAFETY/2002/summary-actos-avandia.PDF
The American Diabetes Association Website: http://www.diabetes.org/

Labels: Actos, Avandia, diabetes, edema, heart attack, myocardial infarction, Type II

After only one month, the FDA has already re-visited the enhanced warnings about the risk of liver damage from acetaminophen, a pain killer medication, better known as Tylenol. On April 28, 2009, the FDA announced that manufacturers of many over-the-counter painkillers and fever reducers would be required to place new warnings on their products of the potential danger of liver damage and stomach bleeding. Since that time, an FDA report has concluded that stronger warnings should be considered, along with better consumer education about these types of commonly used painkillers. The FDA report, which was released May 27, 2009 calls attention to the fact that many people take more than the recommended dose of over-the-counter pain relivers under the assumption that it will be more effective at alleviating the pain, without posing health risks. These unintentional overdoses can lead to severe hepatotoxicity. Consumers simply are not aware of the risks that they may encounter form taking too much of these medications. The recent FDA report calls for these tougher warnings to be applied to not only Tylenol, but also Advil, Motrin, Aleve, and Excedrin. For more information, visit the U.S. National Library of Medicine. If you or a loved one has unexplained suffered liver damage, it could be associated with your use of the over-counter-medications. You may contact the attorneys at Schlichter, Bogard & Denton to discuss your rights.

The Illinois Senate passed Bill 1381 yesterday which would allow for the legalization of medicinal marijuana. The bill will now go to the House for a vote. In order for the bill to pass the Senate, it needed a yes vote from at least 30 senators. The bill passed with a 30-28 vote.
The bill would allow for marijuana to be prescribed by doctors for patients suffering from painful diseases such as HIV/AIDS, glaucoma, cancer, multiple sclerosis, or Crohn’s disease. Patients would only be able to receive a prescription for cannabis from a doctor with whom they have an established relationship with. Once a patient receives a prescription for marijuana, he/she or the primary caregiver would then be able to grow cannabis in their home or retrieve it from a licensed dispensary.
When asked about their motives for passing the bill, many senators expressed purposes for relieving pain and being compassionate. Many senators disapprove of the bill because of concerns about the lack of background checks in the bill. Senator Dale Righter called the bill “an invitation for trouble” because the bill does not require criminal background checks for patients or their caregivers before they are allowed to grow marijuana in their homes.
The bill is now en route to the Illinois House. It is questionable how far the bill will get in the house. This is only the second time that a bill legalizing marijuana has ever reached a vote in either Illinois chamber. As of now, only 13 states have legalized the use of medicinal marijuana, but many other states have proposals pending.

For more information, see:
The Springfield, Illinois newspaper, State Journal-Register, website:
http://www.sj-r.com/archive/x726816166/Medical-marijuana-bill-clears-Senate

And the Saint Louis Post-Dispatch website:
http://www.stltoday.com/stltoday/news/stories.nsf/illinoisnews/story/2151B842BA9B7B76862575C40007E895?OpenDocument

Labels: cancer, cannabis, glaucoma, HIV/AIDS, House, Illinois, marijuana, medicinal marijuana, Senate Judiciary Committee

The U.S. Consumer Product Safety Commission (CPSC) has recently announced the recall of bicycles from a number of manufacturers, including Trek, Cannondale, and Norco. Appoximately 16,000 Trek bikes, 1,500 Cannondale bikes, and 3,600 Norco bikes are affected by the recall.

The problem with the Trek and Cannondale bikes is that the suspension fork loses alignment, causing the front wheel to turn unexpectedly, which can cause the rider to crash. Suspension forks are installed on bikes to give the rider more control in rough areas. The suspension forks on these recalled bikes are manufactured by JD Components and are known as "JD suspension forks". This problem may be seen with any type of bike using a JD suspension fork, not just Cannondale and Trek bikes.

The recalled Trek models are year 2009 Trek 7300, 7300WSD, and 7500 bicycles. The model number is printed on the frame of the bike. The words “Bontrager SPA” are written on the suspension fork. The models were sold nationwide by Trek dealers from August 2008 through April 2009 for $640 to $940.

Trek is asking that owners of these bikes stop riding them immediately and contact their dealer to schedule a free repair. For more information on the Trek recall, call Trek at 1-800-382-2453 or visit their website at www.trekbikes.com. To read the government recall warning and see a photo of the recalled Trek bikes, visit http://www.cpsc.gov/cpscpub/prerel/prhtml09/09224.html.

The recalled Cannondale modeles are year 2008 Cannondale Adventure 2, Adventure 3, Adventure 2 Feminine and Adventure 3 Feminine bicycles. The model name is printed on the frame of the bike. The words “Cannondale AT35 adventure trail” is printed on the suspension fork. The recall does not include bikes using the Rock Shox i-ride fork. The models were sold nationwide by Cannondale retailers from February 2009 through April 2009 for $600 to $800.

Cannondale is asking that owners of these bikes stop riding them immediately and contact their dealer to schedule a free repair. For more information on the Cannondale recall, call Cannodale at 1-800-245-3872 (1-800-BIKE-USA) or visit their website at www.cannondale.com. To read the government recall warning and see a photo of the recalled Cannondale bikes, visit http://www.cpsc.gov/cpscpub/prerel/prhtml09/09225.html

The Norco bikes were recalled not because of the supsension fork, but because the frame can crack and break, causing the rider to crash. The frames were manufactured by Norco Performance Bikes of Canada.

The recalled Norco bikes are models 2007 Team DH, 2008 Team DH, Aline Park, Aline, Atomik, Shore 1,2,3, 2009 Atomik (without gussets). All colors are included in the recall. The model name is printed on a decal on the top tube of each frame/bike. The recalled bikes were sold nationwide at bicycle distributers from September 2006 through February 2009 for $2,000 to $7,000.

Norco is asking that owners of these bikes stop riding them immediately and contact their dealer or Norco directly to schedule a free replacement. For more information on the Norco recall, call Norco at 1-800-663-8916, visit their website at www.norco.com, or email recall@norco.com. To read the government recall warning and see a photo of the recalled Norco bikes, visit http://www.cpsc.gov/cpscpub/prerel/prhtml09/09223.html.

If you have suffered an injury from one of the recalled bikes, you should report your injury to CPSC using the form at the following website: https://www.cpsc.gov/cgibin/incident.aspx. Contact the products liability lawyers at Schlichter, Bogard & Denton for a free review of your case.

Labels: alignment, bicycle, bike, Cannondale, crash, fall, frame, JD, Norco, suspension fork, Trek

On April 16, 2009, the Drug Safety Oversight Board briefly discussed orlistat and the potential risk of hepatotoxicity.

Orlistat is the active ingredient in anti-obesity drugs such as the prescription drug Xenical and the over-the-counter drug Alli.

Xenical is manufactured by Roche, which is headquartered in Nutley, N.J. Alli is manufactured GlaxoSmithKline, which is headquartered in England.

Sue Sutter of Scrip News in her May 21, 2009 article "US FDA examining reports of liver damage with orlistat" gives more details on the relationship between Orlistat and hepatotoxicity.

"Orlistat was discussed in the context of both non-prescription and prescription versions and the potential risk of hepatotoxicity based on several post marketing reports," the FDA told Scrip.

The agency said it was still reviewing the case reports to determine the extent of orlistat's contribution, if any, to the development of liver damage. The FDA declined to provide the number of post marketing reports it has received and said any action would depend upon results of its ongoing analysis....

Roche said more than 35 million patients have been exposed to orlistat therapy, and obesity is a high risk factor for hepatic injury. "The available information – post marketing spontaneous reports, clinical trial data and published literature as well as epidemiology data for drug-induced liver disease – does not suggest that orlistat is causally related to hepatic events."

Currently in Xenical’s package insert there are only rare reports of hepatic, or liver, injury.

The FDA has investigated Orlistat over concerns of rectal bleeding. See: Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008

Any adverse reactions, such as hepatitis, liver injury or liver failure experienced with the use of Xenical or Alli should be reported to the FDA’s MedWatch Program

by phone at 1-800-FDA-1088,
by fax at 1-800-FDA-0178,
by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787,
or on the MedWatch website at www.fda.gov/medwatch.

Labels: Alli, FDA, hepatic, Hepatotoxicity, Liver, MedWatch, Orlistat, Xenical

Mike Tyson’s four-year-old daughter Exodus was taken off life support and pronounced dead on Tuesday. Exodus Tyson’s seven year old brother discovered her Monday hanging from a treadmill cable in the family’s home.

“Somehow she was playing on this treadmill, and there’s a cord that hangs under the console, it’s kind of a loop,” police Sergeant Andy Hill said. “Either she slipped or put her head in the loop, but it acted like a noose, and she was obviously unable to get herself out of it.”

Exodus’s mother took her daughter out of the cable, called 911 and attempted to revive her.

“There are no words to describe the tragic loss of our beloved Exodus,” the family said in a statement. “We ask you now to please respect our need at this difficult time for privacy to grieve and try to help each other heal.”

With the death of Exodus Tyson, attention should be given to the dangers of kids playing on home exercise equipment. The U.S. Consumer Product Safety Commission reported that about 8,700 children under age five- years- old are injured on exercise equipment including treadmills, each year.

This incident is a good reminder that there are hidden dangers in and around your home that you are likely overlook as a hazard to your kids.

Labels: children, dead, life support, mike tyson, treadmill

Labels: bottle, drinks, food, heart disease, plastic, pregnant

The California Supreme Court ruled yesterday that denying gays and lesbians of the right to wed was constitutional under California’s Constitution. In May of last year, the California Supreme Court ruled that same sex marriage was legal in California. But that all changed during the November election when California voters voted on proposition 8 to make same sex marriages illegal. The court ruled in a 6-1 vote that proposition 8 was constitutional under California’s liberal initiative power granted to California citizens. The court refused to apply the ban retroactively, however, and allowed all of the unions that occurred between the prior court opinion and Proposition 8 to stand.
As news of the decision leaked outside, about 1,000 gay rights protestors began chanting “Shame on you.” The same protestors then flooded into the street and began protesting. San Francisco police sent out their lesbian, gay and transgender officers out to specifically deal with the situation. During the protests, 159 adults and 3 juveniles were arrested. Many leaders in the gay community have expressed intentions to try to repeal Proposition 8 at this year’s November elections.

For more information, see:
http://www.cnn.com/2009/US/05/26/california.same.sex.marriage/index.html#cnnSTCText
http://www.msnbc.msn.com/id/30955704/

Labels: california, gay, gay rights, lesbian, marriage, Proposition 8, same sex marriage

Pool chemical injuries account for as many as 5,200 emergency room visits each year. A Centers for Disease Control and Prevention study shows that these injuries are preventable. In 2007 almost half of those injuries occurred in pools at private residences.

Persons can be injured by inhaling fumes when they open pool chemical containers, attempting to pre-dissolve pool chemicals, or handling them improperly. Persons can also be injured when chemicals splash into the eyes. Injuries from pool chemicals can occur in or out of the pool.
In addition to pool chemical injuries, thousands of people each year suffer from recreational water illnesses. These illnesses spread by swallowing, inhaling vapors, or having contact with contaminated water in swimming pools, water parks, spas, interactive fountains, lakes, rivers, or oceans.

“Pool chemicals make the water we swim in safer by protecting us from germs, but these same chemicals can also cause injuries if they are not properly handled,” said Michele Hlavsa, the study′s lead author and epidemiologist at CDC.

Public pool operators and residential pool owners can protect themselves and swimmers by always securing pool chemicals, reading product names and manufacturer’s directions before each use, using appropriate protective gear including safety glasses and gloves, and never mixing chlorine products with each other, with acid, or with any other substance.

The complete set of prevention recommendations is also listed at: www.cdc.gov/healthyswimming/pdf/pool_chem_assoc_inj.pdf.

Swimming is the second most popular sports activity in the United States, with approximately
339 million swimming visits to recreational water venues.

The best way to prevent recreational water illnesses is to keep germs out of the pool. For example, everyone can help create healthy swimming experiences by not swimming when ill with diarrhea, not swallowing pool water, taking kids on bathroom breaks and practicing good hygiene.

Please also see CDC′s Health Swimming Web site at www.cdc.gov/healthyswimming.

Labels: CDC, chemicals, illness, Pool, recreational, swimming

President Obama has chosen Sonia Sotomayor as his U.S. Supreme Court nominee. The President plans to announce this decision at 10:15 a.m. this morning. If Ms. Sotomayor is approved, she will be the first Hispanic U.S. Supreme Court justice. The President’s nominee is a replacement for current Supreme Court Justice David Souter. Justice Souter announced this month that he will be stepping down from the Court when the summer session ends.
Obama was expected to nominate a female to the Supreme Court, which currently only has one female justice, Ms. Ruth Ginsberg. Ms. Sotomayaor has been a federal judge for the U.S. Court of Appeals for the Second Circuit since 1998. From 1992-1998 Ms. Sotomayor was a federal judge for the U.S. District Court, Sothern District of New York. Before that, she served as an assistant district attorney for New York County from 1979-1984.
Once the President nominates a candidate for the Supreme Court, the Senate Judiciary Committee conducts hearings and questions the nominee to determine whether he/she is suitable for the Court. Once the hearings are completed, the Committee votes on whether the Senate should be given a positive, negative or neutral report on the candidate. The entire Senate is then given the report of the Committee and votes on the nominee. A simple majority vote is required to confirm or reject a nominee. Ms. Sotomayor is not expected to have much difficulty being confirmed, as the Senate is Democratic-Controlled. Obama has stated that he hopes to have the hearings in July, with the confirmation completed before Congress leaves for the summer.

For more information see:
http://online.wsj.com/article/SB124334029177454217.html

Labels: Justice, Obama, Senate Judiciary Committee, Sotomayor, Supreme Court

On May 1, 2009, the Food and Drug Administration (FDA) issued two statements about Hydroxycut-branded dietary supplements. In a public advisory, the FDA urged consumers to immediately stop use of Hydroxycut. It talked about the risk of liver injury that had been correlated with Hydroxycut use.

On the same day, the FDA issued a letter to healthcare professionals, describing Hydroxycut products as a "serious public health risk." It talked about reports of 23 cases of liver damage associated with the use of Hydroxycut, some leading to full liver failure, and one to patient death. The letter asked doctors to report liver damage associated with Hydroxycut and review previous cases of hepatitis, characterized by liver injury, to see if they were associated with Hydroxycut use.

In preparing its statement, the FDA informed Iovate Health Sciences, Inc, the manufacturer of Hydroxycut, about its findings. How, exactly, a recall was decided on seems unclear. According to Iovate health Sciences, the company "initiated a voluntary recall when it became aware" of the FDA's findings. According to the FDA statement, "Iovate has agreed to recall" all 14 varieties of Hydroxycut named by the FDA. These varieties are:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

Not all varieties of Hydroxycut have yet been found to be associated with liver damage, but in many cases, injury reports take a long time to reach the FDA. The Hydroxycut-associated death occurred in 2007, but did not reach the FDA until March 2009.

With doctors reviewing past cases of liver damage, it is likely that more cases will be linked to Hydroxycut use. If you suffered liver damage while using Hydroxycut, schedule a Hydroxycut injury lawsuit consultation with the pharmaceutical liability lawyers at Schlichter, Bogard & Denton today.

Labels: attorney, drugs, FDA, Hydroxycut, liver damage

Respironics, the manufacturer of the SmartMonitor 2 Infant Apnea Monitor, announced that it has voluntarily recalled 4,992 infant apnea monitors. The device continuously monitors infant respiration and heart rate in the hospital or in the infant's home or in the hospital. The monitor was designed to detect, and sound an alarm for, periods of temporary interruption of breathing (central apnea) or low heart rates. The FDA announced that the Class 1 recall is necessary to protect consumers from serious injury.

Class 1 is the most serious degree of recall, involving a reasonable probability that use of affected products will cause serious injury or death.

This recall applies to SmartMonitor 2 models 4002 and 4003 -- caregivers and/or parents using a SmartMonitor 2 Infant Apnea Monitor for their infant should contact their homecare provider immediately to determine if their device is affected. However, they should continue using the apnea monitor until it is replaced, unless directed otherwise by a physician.

Any adverse reactions experienced with the use of this device should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Labels: Adverse Events, Class 1 recall, devices, FDA, MedWatch, SmartMonitor

Samsung issued a recall of their "Jitterbug" cellular phones based on concerns that they may not reach 911 in the event of an emergency. The recall was announced on May 22nd by the U.S. Consumer Product Safety Commission (CPSC). Samsung is asking that Jitterbug users upgrade the phone's software.

The recall encompasses approximately 160,000 phones which were sold between March 2008 through May 2009 for about $150.00. The model numbers of the recalled phones are SPH-a110 and SPH-a120.

Samsung is directly contacting Jitterbug users to inform them of the recall. However, users may also contact Samsung at (866) 304-4980.

No injuries or incidents have been reported. The CPSC is asking that any incident or injuries be reported at https://www.cpsc.gov/cgibin/incident.aspx.

For more information and photos of the recalled phones, see http://www.cpsc.gov/cpscpub/prerel/prhtml09/09744.html

Labels: 911, cell phone, cellular phone, emergency, jitterbug, Samsung

On Wednesday, May 20, 2009, President Barak Obama issued a memorandum calling for the rollback of federal preemption of many state law claims. The memo says that federal agencies should only claim that the state law is preempted when there is a valid basis for doing so. While the memorandum did not name any specific industries to be affected by this rollback, many consumer products may be affected.

Preemption generally refers to the displacing effect that federal law will have on state law. This occurs because the Supremacy Clause of the Constitution states that federal law is the supreme law of the land. Therefore, when federal and state laws clash, federal law will take over. Preemption can occur through implied preemption, where it is impossible to comply with both state and federal law or if the state law impedes the achievement of federal objective. Preemption can also occur through express preemption, where agencies and statues will specifically state that they are preempting state law. It was this type of preemption that proliferated under Bush. During the Bush administration, many companies were complaining that they had 50 different state laws to deal with. The Bush administration then spearheaded the issue, encouraging federal agencies to declare rules that stated that state laws were preempted and to make one, uniform federal rule. Bush officials stated that having state consumer safety laws allowed for plaintiffs to get around prohibitions on product liability suits. During the 2008 election, the tort bar discussed with Obama its desire to push back Bush-era regulations.

Even before President Obama’s memo, the tide had already begun to turn on sweeping federal preemption of state law. In March, the U.S. Supreme Court stuck down preemption involving the FDA’s regulation of drugs. In Wyeth v. Levine, a drug manufacturer was sued under state law when one of the manufacturer’s drugs, phenergan, caused a person to develop gangrene. The manufacturer claimed that the FDA’s rule on drug labeling preempted state law. The Supreme Court disagreed. The Supreme Court stated that the FDA supplied the floor for drug labeling requirements and that the drug company would have to comply with all state law labeling requirements as well. Lawsuits against medical device manufacturers are still preempted by state law, but there have been proposals to push legislation that would allow those suits as well.

For more information, see the Wall Street Journal article at:
http://online.wsj.com/article/SB124285702885340713.html

Young children are reportedly developing premature or inappropriate sexual organs from their contact with adult users of testosterone gel. Specifically, young girls developed male sex characteristics, and boys prematurely developed male sex characteristics. The FDA is now requiring two testosterone gel products to have a boxed label warning of these serious side effects.

The gels in question, AndroGel and Testim, are approved for use in men who have extremely low testosterone levels. Women reportedly use testosterone gel to increase libido; this is an off-label, non-FDA approved use of testosterone gel and not recommended. In 2007, there were 1.4 million prescriptions dispensed for AndroGel and just 370,000 for Testim.

AndroGel is manufactured by Solvay of Belgium. Testim is manufactured by Auxilium of Malvern, PA.

Dr. Dianne Murphy, director of the Office of Pediatric Therapeutics at the FDA, suggests that a gel user could have caused the child to come into contact with the gel by forgetting to wash his or her hands or the treated area. Additionally, the gel user may have not waited for skin to dry, and then picked up the child and held him or her.

Children ages 9 months to 5 years are among the eight reported cases the FDA is following. These children suffer from abnormal effects, including inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido and aggressive behavior.

Most of the children's signs and symptoms regressed after they were no longer exposed to the gel. However, a few children still have enlarged genitalia and bone ages higher than the child's chronological age, the FDA said.

One of these children required surgical intervention. Some children also had to undergo invasive diagnostic procedures.

More than a dozen additional reported cases are currently under review by FDA.
The current labels of the two gel products instruct users to wash their hands after use, and to cover treated skin with clothing.

When product users applied gel to body parts that were not indicated in the product's labeling, they "increased the opportunity for a child to be inadvertently exposed," Murphy said.
The FDA recommends that children and women avoid contact with the places where men have applied these products. The agency also recommends that adults who use testosterone gels always do the following:

• Wash hands with soap and water after every application.• Wash the site where the gel was applied with soap and water before coming into skin contact with another person, especially children.

• Cover the application site with clothing when gel has dried.

• Note that the use of non-FDA-approved testosterone gels that can result the same effects should be avoided.

Health care professional and consumers are urged to contact the FDA with adverse event or product quality issues with the contact information below.

--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088

For more information please see: http://www.fda.gov/bbs/topics/NEWS/2009/NEW02011.html

Labels: AndroGel, children, FDA, libido, sex characteristic, testim, Testosterone gel, warning

The danger of E. coli is in the news again! This time, the possible contamination with E. coli is associated with ground beef processed at Valley Meats LLC in Coal Valley, Illinois. The United States Department of Agriculture Safety and Inspection Service has issued a Class I Recall of certain ground beef products. A Class I Recall is merited when there is a likely possiblity that use of the product will cause serious health consequences, including death. E. coli is a poetentially deadly bacteria that can cause bloody diarrhea and kidney failure. The recalled products include, but are not limited to the following brands: 3S Brand Ground Beef Patties andChopped Beef Sirlion Steak Burgers; Grillmaster Brand beef patties; J&B Brand hoagie patties, tenderknit beef steaks, seasoned ground beef patties, tenderknit veal luncheon, and steak burgers; Klub Brand ground beef steaks; and Thick 'N Savory Brand beef products.

All of the ground beef products were produced on March 10, 2009 and distributed nationwide. To date, illnesses have been reported in Illinois, Ohio, and Pennsylvania.

Labels: baby, cancer, children, johnson, products, soap

Attorneys that represent plaintiffs in a lawsuit against the drug manufacturer AstraZeneca, maker of the anti-psychotic Seroquel, planned yesterday to release documents that show that executives in the company discussed promoting the off-label use of Seroquel in children and elderly patients. While there is no evidence that AstraZeneca actually promoted the off-label use of Seroquel, the plaintiffs’ attorneys charge that internal documents show that executives had plans to “broaden Seroquel use on and off label” including among patients with Parkinson’s and Alzheimer’s disease. The same documents also show that executives said that there was a need for “aggressive market penetration” among adolescents, the elderly, and patients with bipolar disorder and other groups in order for Seroquel to grow faster than rivals.

Seroquel was introduced in 1997 to treat psychotic disorders, schizophrenia, and bipolar disorder. Many doctors liked to prescribe Seroquel over other antipsychotics because it has a decreased risk of side effects related to loss of motor control, which many other antipsychotics carry. Seroquel does have its own safety risks, however. The drug has long been linked to weight gain and diabetes, and in 2005 the FDA issued a warning that Seroquel, among other drugs, was linked to death in the elderly. Currently AstraZeneca, the manufacturer of Seroquel, faces over 9,000 lawsuits filed by people who claim that the company withheld information about the antipsychotics’ diabetes risk. AstraZeneca deny that the documents held by the attorneys indicate a desire by AstraZeneca officials to promote off-label uses.

For more information, visit the Wall Street Journal’s online article:
http://online.wsj.com/article/SB123570604586190627.html
For the FDA’s warning, visit: http://www.fda.gov/cder/drug/InfoSheets/HCP/quetiapineHCP.htm

Labels: antipsychotic, drugs, FDA, quetiapine, Seroquel, warning

King Midas, Inc, a California-based food distribution company, has recalled candy imported from Mexico because it contains high levels of lead. Pregnant women and children who have eaten Hola pop! Original Lollipop candy should immediately consult their doctors.

King Midas has warning stores to stop selling its caramel lollipop with a salted apricot in the center. The lollipops come in multiple fruit flavors.

Dr. Mark Horton, director of the California Department of Public Health, recently warned consumers on May 2, 2009 not to eat Hola Pop! La Original Lollipop Candy imported from Mexico after tests found unacceptable high levels of lead. The testing of the candy found that Hola Pop La Original Lollipop Candy contained as much as 0.25 parts per million of lead. California considers candies with lead levels above 0.10 parts per million to be unacceptable and contaminated.

The candy should be discarded immediately.

Consumers who find Hola Pop La Original Lollipop Candy for sale are encouraged to call the California Department of Public Health Complaint Hotline at 1-800-495-3232.

For more information about lead poisoning, please see the CDC website listed below or contact your local county childhood lead poisoning prevention program or public health department.
http://www.cdc.gov/nceh/lead/artificialturf.htm.

For more information about the recall please also see:

http://ww2.cdph.ca.gov/HealthInfo/news/Pages/NR2009-38-HolaPopLaOriginalLollipopCandy.aspx

Labels: california, children, hola pop, lead, lollipops, Mexico, poisoning, pregnant

YAZ is the first birth control pill to combine 20 mcg of ethinyl estradiol (EE) with the so-called "fourth generation" progestin drospirenone (DRSP). Fourth generation progestin drospirenone has antimineralocorticoid properties, which means that it can work against the body's normal mechanism for regulating salt and water balance, a situation that can lead to hyperkalemia in high risk patients, resulting in potentially serious heart and health problems. YAZ was approved by the FDA in March 2006.
A company press release, "FDA Approves YAZ(R), The First Oral Contraceptive To Offer Drospirenone In A 24-Day, Active-Pill Regimen", regarding approval of the drug suggests cardiovascular events are not a concern when using YAZ. The press release states:
YAZ contains 3 mg of the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25-mg dose of spironolactone. YAZ should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction, or adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin-ll receptor antagonists, potassium-sparing diuretics, potassium supplementation medications, aldosterone antagonists and NSAIDs.
In YAZ’s current package insert, the warning above is bolded while serious cardiovascular side effects like deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, and stroke are not emphasized.
The FDA now has some concerns about an association between YAZ and DVT, PE, heart attack, and stroke as demonstrated in the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC) study.
WebMD even lists blood clots such as pulmonary embolism, stroke or heart attacks as rare but very serious side effects of using YAZ.
There are numerous reports of women suffering from a DVT or a PE while using YAZ pills.
The safety concerns surrounding YAZ are similar to the serious and at times fatal side effects of unsafe birth control like Ortho Evra and NuvaRing.
For more information please see: http://www.fda.gov/medwatch/SAFETY/2007/Jan_PI/Yaz_PI.pdf,
http://origin.www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053993.pdf
http://www.medicalnewstoday.com/articles/39844.php, http://clinicaltrials.gov/ct2/show/NCT00335257,
http://www.webmd.com/drugs/mono-656-ETHINYL+ESTRADIOL%2FDROSPIRENONE+24%2F4+-+ORAL.aspx?drugid=95358&drugname=YAZ+28+Oral,

Labels: birth control, cardiovascular, death, Deep Vein Thrombosis, DVT, heart attack, PE, pulmonary embolism, stroke, YAZ

According to a study published by the Journal of the American Medical Association (JAMA), Flomax, a drug used to treat prostate enlargement, may cause serious eye damage if it is used within two weeks before cataract surgery.

The study showed that men who used Flomax within the two weeks prior to their cataract surgery were 2.3 times more likely to suffer an eye injury than those not using Flomax. These men suffered injuries such as detached retinas or lost lenses, which require subsequent surgeries.

The possible reason for this association is that Flomax, which works by relaxing the muscles along the urinary tract, has a similar effect on the muscles around the iris of the eye.

A 2005 study found similar results. Following that study, Boehringer Ingelheim Pharmaceuticals, the Ridgefield, Connecticut-based maker of Flomax, issued a letter to healthcare providers warning them of the association between Flomax and eye injuries. No such letter has been issued with regard to this study. The 2005 letter is available here: http://www.fda.gov/medwatch/safety/2005/Flomax_dearhcp_nov22_PI.pdf

Labels: Boehringer, cataract, detached retina, eye, Flomax, floppy iris, iris, prostate, retina

After four years, the family of a 12 year old boy who fell off an indoor playground at a Riverside County, California Burger King received a $20 million settlement. In 2005, the now severely injured boy and his sister were playing on the playground when the boy fell smashing his head on a tile surface. A negligence lawsuit was filed against Burger King and Delta Marketing, Inc., the installer of the playground. As a result of the injury, the boy suffers from traumatic brain injury, also known as TBI. The boy also suffers from severe injury to the parietal and left front lobes of his brain as well as lung injuries. The boy has had to be hospitalized numerous times including a two month admission to Children’s Hospital in San Diego. The boy still continues rehabilitation for his severe brain injury.


Parents should examine playgrounds closely before allowing their sons or daughters to play. Prior to releasing a child to play, parents should ask: Does the playground have some sort of cushioning underneath, such as a mat? Has the playground been well maintained? If the playground is outside, parents should consider the heat of the day. In the summer, an outdoor slide or swing that has set in the scorching sun can get so hot that it can give your child severe burns.

Labels: Burger King, children, may 20, parent, playground, TBI, traumatic brain injury

A construction worker was killed early Tuesday about 90 miles south of St. Louis while working on the Taum Sauk Reservoir project. The woman’s name has not been released, but it is known that she was 48 years of age and working on a concrete project at the time of the accident. Unidentified co-workers of the woman stated that at about 1:00 a.m. Tuesday the woman was using a blowing machine to blow dust and dirt from concrete when she was struck by a dump truck. The woman may have been wearing earplugs and therefore could not have heard the dump truck coming. Other employees have stated that they have been very concerned for their safety for quite a while and thought that an accident would occur any day.

The woman worked for Ozark Constructors, LLC, which was hired by AmerenUE to rebuild the upper reservoir, which feeds a hydroelectric plant. In December of 2005, the reservoir ruptured and water poured into Johnson Shut-Ins State Park, causing a considerable amount of damage. The Occupational Safety and Health Administration (OSHA) is investigating this accident. OSHA has investigated Ozark Constructors, LLC for two employee-produced complaints about the company in the previous year, neither one resulting in a citation being issued.

http://www.stltoday.com/stltoday/news/stories.nsf/stlouiscitycounty/story/729CBB4A541C9DA5862575BC00104FC7?OpenDocument

Labels: construction, killed, OSHA, Ozark Constructors, Taum Sauk

Levaquin is a popular antibiotic that is commonly prescribed to treat a variety of bacterial conditions or infections involving the lungs, sinuses, skin, bones, joints, and urinary tract. However, Levaquin has been linked to causing serious injuries associated with rupturing tendons. A consumer watchdog group called Public Citizen lobbied the FDA for nearly two years urging the FDA to take action with respect to this dangerous drug - -as the manufacturers of the drug were not acting responsibly. The following link provides an insightful summary of the action initially taken by Public Citizens Group and also the Illinois Attorney General http://www.citizen.org/pressroom/release.cfm?ID=2262 in an effort to protect consumers from the adverse effects associatd with Levaquin. As a result, in July 2008, the FDA issued a black box warning - the most heightened warning possible - alerting physicians and consumers to the link between use of Levaquin and tendinitis, tendon rupture, and other tendon related injuries. See the FDA's black box warning by clicking here http://www.newsinferno.com/archives/3413. The injuries associated with Levaquin often time require surgery, as well as rehabilitation. Presently, many lawsuits have been filed against the manufacturers of Levaquin due to the company's failure to warn of these serious injuries. If you have questions about your use of Levaquin, the adverse effects associated with it, and your legal rights, you may contact us at http://www.druginjuryinformation.com/.

Labels: levaquin, tendon rupture

On Monday, May 18, the FDA issued a class I recall for SmartMonitor 2 Infant Apnea Monitor. A class I recall is the highest recall level that can be issued and is only issued when a product has a reasonable probability of causing serious injury or death. The recalled Apnea monitor is manufactured by Respironics, a Pennsylvania based health care device manufacturer.

The SmartMonitor 2 is used by both hospitals and consumers alike. It is used as a monitoring device in order to continuously watch an infant’s breathing and heart rate. The recall was issued because the SmartMonitor2 can fail to alarm when an infant’s breathing stops or his/her heart rate drops to a dangerously low level. The models that are being recalled were manufactured between January 16, 2008 and November 13, 2008. They were distributed from January 13, 2008 to December 31, 2008. The model numbers being recalled include model 4002 and 4003. The serial numbers of the recalled models are 3000033364 through 3000038740. The FDA advises that all stop using the product immediately and to report any problems to their doctor and the FDA. Currently, there have been no recorded fatalities from this device.

More than 4,900 defective infant apnea monitors have been voluntarily recalled. The potential defect is the failure of the audible alarm, which may cause the alarm not to sound when it should. The FDA stated that on April 23, 2009 Respironics notified medical supply companies of the potential defect in the SmartMonitor 2 infant apnea monitors. Respironics wanted all monitors in the companies’ inventories retuned.
Customers with questions or concerns regarding the SmartMonitor2 infant apnea monitor recall may contact Respironics at 1-888-345-4630.The FDA requests that Health care professionals and consumers may report adverse reactions or quality problems related to the recalled infant apnea monitors to the FDA's MedWatch Adverse Event Reporting program via:
Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
FAX: 1-800-FDA-0178

For more information please see: http://www.fda.gov/MedWatch/safety/2009/safety09.htm#SmartMonitor
http://www.fda.gov/cdrh/recalls/recall-042309.html

Labels: apnea, children, devices, FDA, monitor, recall

The FDA is investigating deaths of two Delaware hospital patients that may be linked to the use of the anti-coagulating drug heparin. The FDA is also investigating life-threatening complications in other patients of the same hospital. In total, 5 patients who were administered heparin suffered complications. An independent laboratory is conducting the investigation. The official cause of the complications is unknown.
Baxter International manufactures the commonly used blood thinner, which has had issues with its safety track record. Last year, Baxter issued a recall on heparin. Though not known at this time, company officials believe that the bulk materials used in the heparin involved in Delaware cases came from North American-based Pfizer, unlike the bulk materials involved the tainted heparin from 2008's recall, which came from China. Heparin’s composition is largely derived from pig intestines, which is why China is a large supplier, as it is a major pork producer. Baxter claims that the recall resulted from the use of an adulterated product, referred to as oversulfated chondroitin sulfate, which came from a Chinese supplier. Baxter is based in Deerfield,
The contaminant found in the heparin recalled in 2008 has not been found in the heparin used by the Delaware patients. Baxter’s vast 2008 recall involved a form of the drug distributed in vials and occurred after numerous complications were linked to it, including complications suffered by Dennis Quaid and Kimberly Buffington’s newborn twins. The heparin involved in the Delaware cases is distributed via a different method than the heparin involved in last year’s recall.
For more information please see: http://www.chicagotribune.com/business/chi-tc-biz-brf-heparin-0512may12,0,2613571.story

Labels: anti-coagulating, China, death, Delaware, Dennis Quaid, FDA, Heparin, Pfizer, recall

The Justice Department and sixteen states have joined in lawsuits alleging that drug giant Wyeth, defrauded the federal government out of millions of dollars. Wyeth has not been a stranger to lawsuits. Just this past November, Wyeth was at the center of a lawsuit regarding a woman’s horrific experience with the drug Phenergan. Diana Levine went to a local health care provider seeking treatment for a migraine. A physician administered Phenergan intravenously. But because the drug was improperly administered, Levine’s arm because gangrenous and ultimately had to be amputated. Levine filed suit against Wyeth arguing that the warning label did not adequately advise or address risks associated with the use of Phenergan.
However, now Wyeth has another big problem to deal with. The lawsuits filed in federal District Court in Massachusetts claim that Wyeth avoided paying hundreds of millions of dollars in rebates to state Medicaid programs for its Protonix Oral and Protonix IV acid- reflux drugs. The compliant alleges that from 2000-2008 Wyeth sold the two medicines to thousands of hospitals at a large discount in a bundled package called the Protonix Performance Agreement.
“By offering massive discounts to hospitals, but then hiding that information from the Medicaid program, we believe Wyeth caused Medicaid programs throughout the country to pay much more for these drugs than they should have”, stated Tony West, assistant Attorney General for the Civil Division, in a news release. Wall Street Journal
Wyeth will likely settle this case before being acquired by Pfizer Inc. later this year.

Labels: drugs, federal, government, lawsuit, Medicaid, migraine, wall street

The manufacturer of Hydroxycut, the brand name associated with several dietary supplements used to help with weight loss, issued a voluntary recall after the FDA issued an advisory on May 1, 2009. The advisory stated the liver damage being caused appears to be relatively rare, but the FDA wanted to warn consumers of unnecessary risks associated with the supplement. The voluntary recall includes 14 Hydroxycut products including Hydroxycut Regular Rapid Release Caplets, Hydroxycut Caffeine-Free Rapid Release Caplets, Hydroxycut Regular Drink Packets, Hydroxycut Liquid Shots, Hydroxycut 24, and Hydroxycut Natural, and others.

Prior to the FDA advisory, the agency received 23 reports of liver-related problems and at least one reported death associated with Hydroxycut products. According to the FDA, at least nine million packages of Hydroxycut products were sold last year. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these products, which contain a variety of ingredients, including herbal extracts.

Side effects associated with Hydroxycut products include jaundice, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite. More severe adverse reactions have included severe liver damage.

For more information about the FDA warning, see http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html

For more information about the Hydroxycut recall, see http://www.fda.gov/oc/po/firmrecalls/iovate205_09.html

Labels: jaundice, liver damage, recall

A report issued by the National Institutes of Health found that those who work with formaldehyde may have a higher risk for certain cancers, particularly blood and lymphatic cancers. The report, issued online on May 12, 2009, is scheduled to be published in print on May 20, 2009 in the Journal of the National Caner Institute.

Formaldehyde is used in certain industries as a preservative and as a disinfectant. Many of these industries use formaldehyde to produce molded-plastic products, decorative laminates, photographic film, or plywood.

The study,which analyzed cancer deaths in over 25,000 industrial workers over 40 years , found a statistically significant association between death from blood and lymphatic cancers and formaldehyde exposure. The specific types of cancers that appear to be associated with formaldehyde exposure include Hodgkin’s lymphoma, multiple myeloma, and myeloid leukemia.

For more information, see http://www.nih.gov/news/health/may2009/nci-12.htm

Labels: cancer, film, formaldehyde, health, Hodgkin's, Hodgkins, institute, laminate, leukemia, lymphoma, myeloma, national, NCI, NIH, plastic

Biosite and FDA notified healthcare facilities and clinicians of the recall of Biosite® brand Triage Cardiac Panel
Biosite and the Food and Drug Administration have recently notified emergency room and hospital laboratory personnel of a Class 1 recall of the Biosite brand Triage Cardiac Panel. FDA defines a Class 1 recall as “the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious injury or death. “
The Biosite ®Triage Cardiac Panel is a test used by hospitals and clinics to assist medical professionals in making the diagnosis of a heart attack. On April 27, 2009, the company sent an urgent recall notice to hospitals and clinics. Facilities were instructed to immediately stop using the tests, and to throw away all packages showing the recalled lot number. Using test kits from the defective lot may lead to false negative results in blood samples containing very low levels of the blood markers used to determine heart damage.
These inaccurate test results can possibly mean that heart attacks, especially in the early stages, were incorrectly diagnosed or missed completely as clinicians relied on incorrect test results as a part of making a correct diagnosis. The defective test kits might not have been sensitive enough to detect low levels of the blood markers to indicate that a person had a heart attack or other damage to the heart muscle.
Testing packets with the recalled lot number were sold to hospitals and clinics from January 24, 2009 through February 17, 2009. If you or a loved one has recently been treated for heart related chest pain or other heart related symptoms, and early signs of a heart attack were missed or incorrectly diagnosed, you may be entitled to compensation.
If you would like to view the complete recall notice, you may do so at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Panel

Labels: Biosite, cardiac, heart attack, javascript:void(0) class 1, misdiagnose, panel, recall, triage

Thousands of homes located in certain states in the midwest and the south, including Alabama, Louisana, and Florida, are contaminated with Chinese Drywall. Due to the construction boom a few years ago, many contractors purchased drywall from manufacturers in China. This drywall gives off sulfurous odor when heated, causing homes to have a rotten egg like smell and often times results in turning the coils of air conditioners to become black. In addition, the toxins from the dryall causes appliances to fail. This drywall not only causes damages to homes, resulting in reconstruction work to the walls, but also causes health hazards to the occupants. Many people have reported physical symptoms associated with this type of drywall, including dizziness, headaches, fatiuge, irritation to the skin and eyes, and respiratory problems. At least one of the companies that is known to have manufactured this tainted dry wall is Knauf Plasterboard Tianjin - -its drywall is stamped with the product label, "Knauf-Tianjin." Consumer Product Saftey Commissions have received thousands of complaints. If you would like more informaiton about the litigation associated with this harmful product, plesae contact Schlichter, Bogard & Denton.

People who live near coal waste deposit sites may be at risk of suffering damaging health effects. This announcement was made recently by two environmental groups, the Environmental Integrity Project and Earthjustice, in a report which stated that coal waste has polluted water in at least 24 states and at more than 70 sites around the United States.

Coal waste, or coal ash, is a byproduct produced by coal-burning power plants, which constitute the majority of the power plants in the United States. These plants generally store coal waste in ponds or landfills. Often, the waste ponds and landfills have inadequate lining that allows chemicals from the waste to leach into drinking water.

Coal waste contains lead, arsenic, cadmium, cobalt and other harmful metals. These chemicals are known to cause cancer, liver damage, lung disease, gastrointestinal problems, birth defects, and a number of other serious injuries.

The highest risk of coal waste leaching into drinking water is near the sites of older coal waste storage facilities, as these landfills and ponds are more likely to lack liners or to have damaged liners.

Despite the toxic risks of coal combustion waste, there are no national standards for storing or disposing of it. Some states require companies that produce coal waste to obtain permits and other states monitor water for leached chemicals, however, regulations vary greatly from state to state. Even in states that do regulate coal waste, there is still a risk of leaching from older structures that have damaged liners or lack liners completely. A list of the 100 most polluting coal plants is available here.

In December, 2008, a dam at a coal plant in Harriman, Tennessee collapsed, releasing over one billion gallons of toxic coal waste over 300 acres of land, poisoning water with hazardous chemicals. While the risk of this type of disaster is serious, the risk of leaching from coal waste ponds and landfills is even more alarming, as it occurs constantly and is generally unmonitored.

Contaminated water has also been discovered recently in Crestwood, Illinois and Camp Lejeune, North Carolina, though the contaminated wells in those locations were polluted by sources other than coal waste storage sites.

See the following links for more information:

http://www.thesouthern.com/articles/2009/01/25/front_page/27857494.txt

https://www.istockanalyst.com/article/viewnewspaged/articleid/2980037/pageid/2

Labels: ameren, arsenic, cancer, coal, coal ash, coal plant, coal waste, combustion, hazardous, lead, poisoning, pollution, power plant, toxic, water

Did you know that the medications used to cleanse your bowels before having a colonoscopy performed or other surgeries can cause you to go into kidney failure? These medications are known as Oral Sodium Phosphates; some of which are prescription medications and some of which are over-the-counter. The prescription products include Visicol and Osmo Prep and over-the-counter medications inlcude Fleet Phospho-Soda and Fleet Accu-Prep. Recently the FDA has issued black box warnings associated with many of these products. If you have taken one of these medications - Osmoprep, Visicol, Fleet Phosphosoda, or Fleet Accuprep - and have suffered kidney failure following your use of these medications, the attorneys at Schlichter, Bogard & Denton can assist you. For more information about the FDA's action involving these products, click here: http://www.fda.gov/consumer/updates/bowel_cleansers121608.html

Labels: bowel cleansing, colonoscopy side effects, fleet accu-prep, fleet accuprep, fleet phospho-soda, fllet phosphosoda, kidney failure, oral sodium phosphate, osmo prep, osp, phosphate nephropathy, visicol